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When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with supplemental fixation.

When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

The Lanx Fusion System devices are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The implant has a hollowed out area to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws which are made from an implant grade titanium alloy (Ti-6AI-4V ELI) meeting the requirements of ASTM F136. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The purpose of this submission is to expand the available plate options for the Lanx Lateral-SA implants. The Lanx Fusion System is provided non-sterile.

Here's an analysis of the provided text regarding the Lanx Fusion System, focusing on acceptance criteria and study details.

Based on the provided {0}-{5} text, this is a 510(k) summary for a spinal implant (Lanx Fusion System) seeking FDA clearance. The document describes the device, its intended use, and claims substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study that "proves the device meets the acceptance criteria" in the way a clinical study for an AI/CADe device would.

Instead, the "Performance Data" section specifically refers to bench testing and engineering analysis performed to demonstrate substantial equivalence for a medical device implant. It evaluates mechanical properties of the implant, not diagnostic accuracy in interpreting medical images or data.

Therefore, many of your requested points regarding AI/CADe system evaluation metrics (such as test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of device submission.

Here's a breakdown of the requested information based on the provided text, indicating where information is present and where it is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Compliance with ASTM F2077 (static/dynamic compression, static compression shear, static torsion)	"In all instances, the modified device met or exceeded predicate device performance, functioned as intended..." (Implies compliance with F2077). Specific numerical performance values are not provided nor are the specific acceptance thresholds for these tests in this summary. Instead, it states the device met or exceeded the predicate device's performance.
   Compliance with ASTM draft expulsion testing standard Z8423Z (expulsion tests)	"...met or exceeded predicate device performance, functioned as intended..." (Implies compliance with Z8423Z). Specific numerical performance values are not provided.
   Compliance with ASTM F1877 (wear debris)	"...met or exceeded predicate device performance, functioned as intended..." (Implies compliance with F1877). Specific numerical performance values are not provided.
   Substantial Equivalence to predicate device (K123767)	"The modified Lanx Fusion System implants... have the same intended use, indications, technological characteristics, and principles of operation as the previously cleared Lanx Fusion System devices (K123767). The minor differences... do not raise any new issues of safety or effectiveness. Performance data presented also demonstrated comparable properties..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable / Not Provided. This document describes mechanical bench testing of an implant, not a clinical study involving a "test set" of patient data in the typical sense. The "performance testing" refers to physical tests on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable / Not Provided. Ground truth by medical experts is relevant for diagnostic devices or AI systems. This is an implant, and its performance is evaluated physically against engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable / Not Provided. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations. This is not a clinical study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not Applicable / Not Provided. MRMC studies are specifically for evaluating diagnostic performance, often for AI/CADe systems. This device is an implant for spinal fusion and replacement, not a diagnostic tool or an AI system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • Not Applicable / Not Provided. This concept applies to AI algorithms. The Lanx Fusion System is a physical medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not Applicable. The "ground truth" for this device's performance would be the established engineering standards (ASTM F2077, ASTM draft Z8423Z, ASTM F1877) and the performance characteristics of its predicate device.

8. The sample size for the training set

   • Not Applicable / Not Provided. This is a physical implant, not an AI system that requires a "training set."

9. How the ground truth for the training set was established

   • Not Applicable / Not Provided. As above, this is not an AI system. "Ground truth" for its design and manufacturing would come from engineering specifications, material properties, and regulatory standards.

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The Lanx Spinal Fixation System (SFS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

The purpose of this 510(k) submission is to modify the Surgical Technique for the Lanx Spinal Fixation System. No other changes have been made to the previously cleared system.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

The Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, ASTM F136 and ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

This document is a 510(k) summary for a medical device (Spinal Fixation System), not a study report for an AI/algorithm-driven device. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm.

The request asks for details like:

• A table of acceptance criteria and reported device performance (for an AI/algorithm).
• Sample sizes, data provenance, expert ground truth establishment for a test set.
• Adjudication methods, MRMC studies, standalone performance, ground truth types.
• Training set details.

The provided document states: "Performance Data: No performance data was submitted to determine substantial equivalence." This means the submission is not based on new performance testing but rather on demonstrating substantial equivalence to a previously cleared predicate device due to a minor change (modification to the Surgical Technique).

Essentially, this device is a physical spinal implant, not an AI software/algorithm that would have "acceptance criteria" and "study results" in the way described in the prompt. The "performance data" if it were submitted for this type of device would typically relate to mechanical testing (e.g., fatigue, static strength) or biocompatibility, not clinical study outcomes or AI algorithm metrics.

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When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior, approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone grafi in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with supplemental fixation.

When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. TI- L5) for partial replacement (i.e., partial vertebrectonv) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

The purpose of this 510(k) submission is to include additional PEEK spacer and titanium screw fixation configurations to the Lanx SA System. The new Lanx Lateral-SA system has the same intended use, principles of operation, and technological characteristics as the current Lanx SA svstem.

The Lanx Lateral-SA System devices are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6AI-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Fusion System has a hollowed out area to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws which are made from an implant grade titanium alloy (Ti-6AI-4V ELI) meeting the requirements of ASTM F136. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Lateral-SA System is provided non-sterile.

The Lanx Lateral-SA System is a medical device intended for spinal fusion procedures and vertebral body replacement. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document describes performance testing and engineering analysis to demonstrate substantial equivalence. It does not provide specific sample sizes (e.g., number of devices tested) for the ASTM tests mentioned (F2077, F2267, F1877). These tests typically involve a defined number of samples to ensure statistical validity, but the exact count is not disclosed in this summary.

The data provenance is laboratory-based engineering testing, rather than clinical data from human subjects. The report does not mention any country of origin for the data beyond being submitted to the FDA in the US, nor does it specify if the testing itself was retrospective or prospective in a clinical sense. It's prospective in the context of device development.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This submission relies on engineering and performance testing against established ASTM standards, not on expert interpretation of medical images or patient outcomes. Therefore, there's no "ground truth" in the sense of expert consensus on clinical findings.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. There was no clinical study involving human readers or interpretation requiring adjudication. Performance was evaluated against objective engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This document does not describe an MRMC study or any study involving human readers with or without AI assistance. The submission focuses on the mechanical and material equivalence of the device to its predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device (spinal implant), not a software algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant here.

7. The Type of Ground Truth Used:

The ground truth for the performance claim is based on established engineering standards (ASTM F2077, ASTM F2267, ASTM F1877) and a comparison to the mechanical properties of a predicate device (K102738). The "ground truth" is that the device must meet or exceed the performance of the predicate device under these standardized conditions.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As described above, there is no "training set" in the context of this device's evaluation.

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The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

The purpose of this 510(k) submission is to add an adjustable-length spinous process fusion plate to the Lanx Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

The Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, ASTM F136 and ASTM F136 and ASTM F1537, Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

This 510(k) summary describes a spinal fixation system, which is a physical device rather than a software or AI-driven medical device. Therefore, many of the requested categories related to acceptance criteria, ground truth, expert review, and comparison to AI performance are not applicable.

Here's a breakdown of the available information based on your request, highlighting where the information is not relevant for a physical medical device:

Acceptance Criteria and Device Performance for Lanx Spinal Fixation System (K121316)

The submission focuses on demonstrating the substantial equivalence of new components (an adjustable-length spinous process fusion plate) to a previously cleared system and predicate devices. The "acceptance criteria" are primarily related to mechanical performance standards.

Information Not Applicable to this Device (Physical Spinal Fixation System):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for mechanical testing of a physical implant. The "test set" here refers to the physical samples of the device components.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is established by engineering standards and measurements, not expert clinical interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/software device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the objective performance standards outlined in the ASTM standards (e.g., specific force, displacement, or fatigue cycles).
7. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical testing of a physical medical device.
8. How the ground truth for the training set was established: Not applicable.

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The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The modifications contained herein consist of the addition of pedicle screw sizes to the SFS system.

The provided 510(k) summary for the Lanx Spinal Fixation System (K122145) describes a device modification, specifically the inclusion of additional pedicle screw sizes. As such, the submission primarily focuses on demonstrating substantial equivalence to the previously cleared predicate device rather than conducting a de novo study with acceptance criteria and a detailed comparative study for a novel device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not provide a table of explicit, quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Engineering analysis" and "Engineering analyses" but does not specify:

• The sample size of any test set (e.g., number of pedicle screws or constructs tested).
• The data provenance (e.g., country of origin, retrospective or prospective nature).

These analyses would typically involve mechanical testing (e.g., fatigue, static strength) of various screw sizes and configurations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This type of information is not applicable to this 510(k) submission. For a device modification like this, where the focus is on mechanical properties and substantial equivalence, "ground truth" established by experts in an clinical or imaging context is not relevant. The "ground truth" would be established by engineering standards and test methodologies.

4. Adjudication Method for the Test Set:

This is not applicable for the type of engineering analysis described. Adjudication methods (like 2+1, 3+1) are typically used for clinical or image-based studies where multiple readers assess outputs against a reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-interpretation devices, not for a spinal fixation system modification focused on mechanical properties. Thus, there is no mention of the effect size of human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:

No, a standalone study was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on engineering standards and established mechanical test methodologies to evaluate the mechanical performance of the pedicle screws and the overall system. The comparison is made against the predicate device's known performance and relevant ASTM or ISO standards for spinal implants.

8. The Sample Size for the Training Set:

This concept is not applicable to this submission. The device is not an AI/machine learning model that requires a "training set." The engineering analyses performed are deterministic mechanical tests.

9. How the Ground Truth for the Training Set was Established:

This is not applicable as there is no "training set" for this device.

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The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-SI). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondvlolisthesis: trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

The purpose of this 510(k) submission is to add modified plates to the Lanx Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

The Lanx Spinal Fixation System implants are fabricated from medical grade titanium alloy and/or cobalt chrome alloy per ASTM F67. ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

The provided text is for a 510(k) premarket notification for a medical device, the Lanx Spinal Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed performance studies typically associated with AI/ML devices or novel technologies.

Therefore, the information requested in your prompt (acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable or available within this document.

Here's why and what information is provided:

Explanation Regarding Missing Information:

This 510(k) submission for the Lanx Spinal Fixation System is for an orthopedic implant. For such devices, regulatory clearance is typically based on:

• Substantial Equivalence: Demonstrating that the new device has the same intended use, technological characteristics, and principles of operation as legally marketed predicate devices, and that any differences do not raise new issues of safety or effectiveness.
• Performance Testing (Benchtop): This usually involves mechanical and material testing to ensure the device meets engineering specifications and is comparable to predicates. It does not involve "performance" in the sense of predictive accuracy or diagnostic capability, which is relevant for AI/ML.

Information Extracted from the Document (and why other items are not applicable):

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical or diagnostic performance, as this relates to a mechanical device.
   • Reported Device Performance:
     • Performance Test: Static torsion tests using modified ASTM F 1717 methods.
     • Outcome: "The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

   • N/A: The "test set" in this context refers to physical test specimens for mechanical testing, not a dataset for evaluating an algorithm. The document does not specify the number of physical components tested.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

   • N/A: Not applicable for mechanical device testing.

4. Adjudication Method for the Test Set:

   • N/A: Not applicable for mechanical device testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • N/A: This is not an AI/ML device, so MRMC studies are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A: This is not an AI/ML device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

   • N/A: For mechanical testing, the "ground truth" would be the engineering specifications and established mechanical properties of the materials and design.

8. The Sample Size for the Training Set:

   • N/A: This is not an AI/ML device, so there is no training set.

9. How the Ground Truth for the Training Set was Established:

   • N/A: This is not an AI/ML device.

Additional Relevant Information from the Document:

• Device Type: Spinal Fixation System (orthopedic implant).
• Purpose of Submission: To add modified plates to an existing system.
• Materials: Medical grade titanium alloy and/or cobalt chrome alloy (ASTM F67, ASTM F136, ASTM F1537).
• Basis for Clearance: Substantial Equivalence to previously-cleared Lanx Spinal Fixation Systems (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K100935, K103091, K103237, K120399, K120682).
• Conclusion: "The modified Lanx Spinal Fixation System has the same intended use, indications, technological characteristics, and principles of operation as the predicate system. The differences in the modified components do not raise any new issues of safety or effectiveness. Testing also demonstrated comparable properties to the previously cleared Lanx Spinal Fixation System. Thus, the modified Lanx Spinal Fixation System is substantially equivalent to the predicate device."

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When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• . Spondylolisthesis
• Spinal Stenosis ♥
• . Trauma/Fracture/Dislocation
• Atlanto-Axial Fracture with Instability .
• Occipito-Cervical Dislocation .
• . Failed Previous Fusion
• . Tumor

The use of occipital bone screws is limited to placement in the occiput only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-73) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, with the anchors and connectors rigidly locked to the rod, allowing the surgeon to tailor the construct to the particular needs of the patient.

The Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy per ASTM F136 and cobalt chrome alloy per ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

The Lanx Posterior Cervicothoracic Spinal Fixation System is a medical device for spinal fixation.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The study was non-clinical (mechanical testing), so concepts like "test set" in the context of patient data or "data provenance" (country of origin, retrospective/prospective) are not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the study was non-clinical (mechanical testing). Ground truth in this context would refer to established engineering standards (ASTM F1717), not expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the study was non-clinical mechanical testing, not a clinical study involving human assessment or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed. The study was non-clinical mechanical testing comparing the modified device to a predicate device.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense of a laboratory-based mechanical test of the device itself. The "algorithm only" aspect of the question is not relevant here as this is a physical medical device. The study characterized the modified Lanx Posterior Cervicothoracic Spinal Fixation System's mechanical performance.

7. Type of Ground Truth Used

The "ground truth" for this non-clinical study was the established mechanical testing standard, ASTM F1717. The performance of the modified device was compared against the performance of the predicate device under these standardized conditions to demonstrate substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable as there was no "training set" in the context of an algorithm or machine learning. The study involved mechanical testing of the physical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

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The Lanx Cervical SA System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Lanx Cervical SA is to be filled with autogenous bone graft material, and is to be used with titanium alloy screws which accompany the implant.

The product includes the Lanx Cervical SA PEEK implant models with titanium components for additional fixation. All devices in the Lanx Cervical SA System are made of PEEK-OPTIMA® LT1 per ASTM F2026 and/or Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Lanx Cervical SA implants have a central cavity to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws and plates which are made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136. The device is available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Cervical SA System is provided non-sterile.

The provided information describes a medical device submission (510(k) summary) for the Lanx Cervical SA Intervertebral Body Fusion System. The core of this document focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance of a novel AI/software-as-a-medical-device (SaMD) through a clinical study with detailed acceptance criteria and expert reviews.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of traditional medical device submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable: This document describes mechanical performance testing of an implantable device, not a classification or diagnostic AI/SaMD. The "test set" in this context refers to the physical samples of the device used for mechanical stress tests according to ASTM standards. The specific number of physical units tested is not detailed, but it would adhere to the sample size requirements inherent in each ASTM standard. Data provenance is implicitly from the manufacturing facility where the device was produced for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: Ground truth, in the context of expert consensus, pathology, or outcomes data, is not relevant here. The "ground truth" for mechanical testing is defined by the established parameters and failure modes specified in the ASTM standards. Experts involved would be engineers conducting and interpreting the mechanical tests according to standard protocols, not medical experts establishing diagnostic ground truth.

4. Adjudication method for the test set

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in diagnostic studies. For mechanical testing, the results are quantitative measurements against predefined criteria in the ASTM standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This device is a physical intervertebral body fusion system, not an AI or SaMD requiring human reader studies.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

• Not Applicable: This is a physical medical implant, not an algorithm.

7. The type of ground truth used

• Mechanical Specifications/Standards: The "ground truth" for this device's performance is against established engineering and mechanical standards (e.g., ASTM F2077, F2267, F136, F2026, F560) which specify material properties, dimensions, and performance under various loads. The device must meet these predefined physical and performance characteristics.

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device; therefore, there is no "training set."

9. How the ground truth for the training set was established

• Not Applicable: As above, no training set. The "ground truth" for mechanical criteria is established by recognized national and international engineering standards (ASTM).

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The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondylolisthesis: trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

The Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

The provided text describes a 510(k) summary for the Lanx Spinal Fixation System, focusing on mechanical performance testing rather than performance in a clinical or diagnostic setting. Therefore, the questions related to clinical study design, human readers, ground truth establishment, and sample sizes for training sets are not applicable to the information contained in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to a comparison with a predicate device and adherence to ASTM standards. It does not explicitly state numerical acceptance criteria in a table format, but rather indicates that the modified device's performance was comparable to the predicate device and functioned as intended.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in the document. The testing involved "the modified and predicate systems," implying an engineering test setup rather than a patient-based test set. The number of samples for each mechanical test (e.g., number of constructs tested) is not provided.
• Data Provenance: The data is generated from laboratory performance testing and engineering analysis of the physical device components. This is not patient-based data, so concepts like "country of origin" or "retrospective/prospective" do not apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and the physical properties of the materials and designs under controlled laboratory conditions, not by expert medical opinion.

4. Adjudication method for the test set:

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when human expert consensus is required for ground truth. For mechanical testing, the "adjudication" is inherent in the adherence to established testing protocols and the direct measurement of physical properties.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. This document describes a mechanical spinal fixation system, not an AI-based diagnostic or treatment tool that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This document describes a physical medical device (spinal fixation system), not an algorithm or software.

7. The type of ground truth used:

The "ground truth" for the performance testing is based on established engineering standards (ASTM F1717) for static and dynamic axial compression and static torsion, as well as additional expulsion, sheer, and compression tests. The performance of the modified device was compared directly to that of a predicate device under these standardized testing conditions.

8. The sample size for the training set:

This question is not applicable. The document describes a physical medical device undergoing mechanical performance tests, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This question is not applicable for the reasons stated in point 8.

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The Lanx Spinal Fixation System (SFS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single-level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx Spinous Process Fusion Plate is intended for use with bone graft material, not intended for standalone use.

The purpose of this Special 510(k) is to add a modified polyaxial pedicle screw configuration in multiple sizes. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

The Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

The provided document describes the Lanx Spinal Fixation System, a medical device, and its regulatory submission. It does NOT contain information about acceptance criteria or a study proving that a device (in the context of AI/software performance) meets acceptance criteria.

The document discusses:

• Device Identification: Proprietary Name, Common Name, Classification, Predicate Devices.
• Intended Use / Indications for Use: What the system is designed to do and for what conditions.
• Device Description & Technological Characteristics: Details about its components, materials, and the purpose of the 510(k) (adding a modified polyaxial pedicle screw configuration).
• Performance Data: States that mechanical performance testing was conducted according to ASTM standards (F1717 and F1798) to characterize the modified components. The results "demonstrate substantial equivalence to the predicate device."
• Substantial Equivalence: A conclusion that the modified components are substantially equivalent to the predicate device based on intended use, technological characteristics, and mechanical testing.
• FDA Letter: A letter from the FDA confirming the 510(k) clearance for the Lanx Spinal Fixation System based on substantial equivalence.

Therefore, I cannot extract the requested information as it pertains to AI/software device performance criteria and studies. The document is about a mechanical orthopedic implant system and its regulatory clearance based on mechanical testing and substantial equivalence to existing devices.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: This document does not specify numerical acceptance criteria for AI/software performance metrics (e.g., sensitivity, specificity, accuracy) or report such performance for an AI/software device. It mentions mechanical testing (ASTM F1717 and F1798) and states that the "observed test results demonstrate substantial equivalence to the predicate device." The acceptance criteria for this mechanical testing would be implicit in the ASTM standards and the demonstration of equivalence, but specific numbers are not provided in terms of "reported device performance" in a table.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software study. "Test set" in this context would refer to the physical components tested mechanically, not a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving human experts establishing ground truth for software performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI study.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of AI/software. For the mechanical testing, the "ground truth" would be the established performance characteristics and safety profile of the predicate device against which the modified device was compared.
8. The sample size for the training set: Not applicable. This is not an AI study involving a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a Spinal Fixation System and its regulatory clearance based on mechanical testing and substantial equivalence, not the performance of an AI-powered diagnostic/analytic device.

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